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Monoclonal Antibodies

YH001 + Envafolimab for Sarcoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Tracon Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Left ventricular ejection fraction (LVEF) as measured by echo or multigated acquisition scan of > 50% (for patients to receive doxorubicin)
Histologically confirmed advanced or metastatic sarcoma patients without UPS or MFS who are refractory to or intolerant to standard treatments for their disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 25 months
Awards & highlights

Study Summary

This trialtests a new treatment for advanced or metastatic sarcoma, combining YH001, envafolimab, & doxorubicin. Results will help decide if it can help certain types of sarcoma.

Who is the study for?
Adults with advanced or metastatic sarcoma, except for UPS or MFS types, who haven't had immune checkpoint inhibitors or doxorubicin. They should have measurable disease and good organ function. Women must not be pregnant and agree to birth control; men must use a condom if not sterile.Check my eligibility
What is being tested?
The study is testing YH001 in combination with Envafolimab, and then adding Doxorubicin for certain patients. It's an open-label trial meaning everyone knows what treatment they're getting, starting with Phase 1/2 followed by specific patient groups in Phase 2.See study design
What are the potential side effects?
Possible side effects include those common to immunotherapy and chemotherapy such as fatigue, nausea, increased risk of infection, allergic reactions to the drugs' components, heart issues especially related to Doxorubicin use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart pumps well, with an ejection fraction over 50%.
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My advanced sarcoma is not responding to standard treatments.
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I am 18 years old or older.
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I am sterile or I agree to use a condom with spermicide.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~25 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 25 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Determine recommended phase 2 dose of YH001 in combination with Envafolimab
Phase 1: Determine recommended phase 2 dose of YH001 in combination with Envafolimab with Doxorubicin
Phase 2: Determine the objective response rate (ORR) of YH001 in combination with Envafolimab
+1 more
Secondary outcome measures
Phase 1: Assessment of antitumor activity
Phase 1: Determine the Rate of Envafolimab Immunogenicity
Phase 1: Determine the Rate of YH001 Immunogenicity
+11 more

Trial Design

8Treatment groups
Experimental Treatment
Group I: P2: Sarcoma Subtype 4 RP2D YH001 + Dose 1 Envafolimab + Doxorubicin Q3WKExperimental Treatment3 Interventions
Recommended Phase 2 Dose of YH001 in combination with Dose 1 of Envafolimab every 3 weeks and Doxorubicin every 3 weeks for a maximum of 6 doses
Group II: P2: Sarcoma Subtype 3 RP2D YH001 + Dose 1 Envafolimab + Doxorubicin Q3WKExperimental Treatment3 Interventions
Recommended Phase 2 Dose of YH001 in combination with Dose 1 of Envafolimab every 3 weeks and Doxorubicin every 3 weeks for a maximum of 6 doses
Group III: P2: Sarcoma Subtype 2 RP2D YH001 + Dose 1 Envafolimab Q3WKExperimental Treatment2 Interventions
Recommended Phase 2 Dose of YH001 in combination with Dose 1 of Envafolimab every 3 weeks
Group IV: P2: Sarcoma Subtype 1 RP2D YH001 + Dose 1 Envafolimab Q3WKExperimental Treatment2 Interventions
Recommended Phase 2 Dose of YH001 in combination with Dose 1 of Envafolimab every 3 weeks
Group V: P1 Cohort 2B: Dose 2 YH001 + Dose 1 Envafolimab + Doxorubicin Q3WKExperimental Treatment3 Interventions
Dose 1 of YH001 will be dosed in combination with Dose 1 of Envafolimab with Doxorubicin every 3 weeks.
Group VI: P1 Cohort 2A: Dose 2 YH001 + Dose 1 Envafolimab Q3WKExperimental Treatment2 Interventions
Dose 1 of YH001 will be dosed in combination with Dose 1 Envafolimab every 3 weeks.
Group VII: P1 Cohort 1B: Dose 1 YH001 + Dose 1 Envafolimab + Doxorubicin Q3WKExperimental Treatment3 Interventions
Dose 1 of YH001 will be dosed in combination with Dose 1 of Envafolimab with Doxorubicin every 3 weeks.
Group VIII: P1 Cohort 1A: Dose 1 YH001 + Dose 1 Envafolimab Q3WKExperimental Treatment2 Interventions
Dose 1 of YH001 will be dosed in combination with Dose 1 Envafolimab every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
FDA approved
YH001
2020
Completed Phase 1
~50
Envafolimab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Tracon Pharmaceuticals Inc.Lead Sponsor
21 Previous Clinical Trials
1,039 Total Patients Enrolled
James Freddo, MDStudy DirectorMedical Monitor
1 Previous Clinical Trials
72 Total Patients Enrolled

Media Library

Envafolimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05448820 — Phase 1 & 2
Soft Tissue Sarcoma Research Study Groups: P2: Sarcoma Subtype 1 RP2D YH001 + Dose 1 Envafolimab Q3WK, P2: Sarcoma Subtype 4 RP2D YH001 + Dose 1 Envafolimab + Doxorubicin Q3WK, P1 Cohort 2A: Dose 2 YH001 + Dose 1 Envafolimab Q3WK, P1 Cohort 1B: Dose 1 YH001 + Dose 1 Envafolimab + Doxorubicin Q3WK, P1 Cohort 1A: Dose 1 YH001 + Dose 1 Envafolimab Q3WK, P2: Sarcoma Subtype 2 RP2D YH001 + Dose 1 Envafolimab Q3WK, P1 Cohort 2B: Dose 2 YH001 + Dose 1 Envafolimab + Doxorubicin Q3WK, P2: Sarcoma Subtype 3 RP2D YH001 + Dose 1 Envafolimab + Doxorubicin Q3WK
Soft Tissue Sarcoma Clinical Trial 2023: Envafolimab Highlights & Side Effects. Trial Name: NCT05448820 — Phase 1 & 2
Envafolimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05448820 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation currently have vacancies for participants?

"The investigation, which had its initial launch on November 14th 2022 is currently recruiting patients. Information posted to clinicaltrials.gov has been updated as recently as December 5th 2022."

Answered by AI

What overall goals is this experiment attempting to achieve?

"The primary purpose of this medical trial, which will last around 8 months, is to assess the objective response rate (ORR) of YH001 when administered with envafolimab and doxorubicin. Secondary objectives include determining the trough concentrations of both YH001 and envafolimab as well as YH001's concentration in isolation from other drugs."

Answered by AI

What is the aggregate participant count for this exploration?

"Indeed, according to the information on clinicaltrials.gov this research is actively recruiting participants after being posted on November 14th 2022 and updated most recently on December 5th 2022. 176 individuals need to be recruited from a single site for this study."

Answered by AI
~6 spots leftby Mar 2025